Dosage and administration
Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
Generic Hand Sanitizer
- Manufacturer
- Frozen Wheels,Llc
- Effective date
- 2020-05-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:10:41
Label at a glance#
ProductGeneric Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections
Storage and handling
Store between 15-30°C (59-86°F) Avoid freezing and excessive heat above 40°C (104°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Alcohol 75% v/v
Purpose
Antiseptic
Use[s]
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
WARNINGS SECTION
Warnings For external use only.
Flammable. Keep away from heat or flame
Do not use
- in children less than 2 months of age
- on open skin wounds
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other information
- Store between 15-30°C (59-86°F)
- Avoid freezing and excessive heat above 40°C (104°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients glycerin, hydrogen peroxide, purified water USP
SPL UNCLASSIFIED SECTION
75% ALCOHOL ANTISEPTIC
Topical Solution
Non-sterile Solution
NO ANIMAL TESTING
parabens FREE
Made in México.
Imported & distributed by:
Frozen Wheels, LLC
16565 NW 15th Ave.
Miami, FL 33169
QUESTIONS
786-265-1879
NOT INTENDED FOR RETAIL SALE
Packaging
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 77031-808-16 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-29a0-fd44-e053-dadaa90aa01b | HAND SANITIZER |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77031-808-16 | Generic Hand Sanitizer | 500 mL in 1 BOTTLE, PLASTIC | SOLUTION | 500 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Generic Hand Sanitizer
- Alcohol
- GLYCERIN
- HYDROGEN PEROXIDE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 77031-808 | 77031-808-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e85f1334-10b6-4bd3-9cb2-255522cc7faa | 0bc05dc9-4cf3-4352-997d-e318ced9c067 | 2020-05-11 | Warnings | e85f1334-10b6-4bd3-9cb2-255522cc7faa 0bc05dc9-4cf3-4352-997d-e318ced9c067 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.